UNITED STATES DISTRICT COURT

SOUTHERN DISTRICT OF INDIANA

INDIANAPOLIS DIVISION
ELI LILLY AND COMPANY, )
DAIICHI SANKYO CO., LTD., )
DAIICHI SANKYO, INC., )
and UBE INDUSTRIES, LTD., )
)
Plaintiffs, )
v. ) CASE NO. 1:14-cv-1135
)
HEC PHARM CO., LTD., and )
HEC PHARM USA INC., )
Defendants. )
COMPLAINT FOR PATENT INFRINGEMENT
Eli Lilly and Company, Daiichi Sankyo Co., Ltd., Daiichi Sankyo, Inc., and Ube
Industries, Ltd. (collectively, Plaintiffs), for their Complaint against defendants HEC Pharm
Co., Ltd. (HEC Pharm) and HEC Pharm USA Inc. (HEC Pharm US) (collectively, HEC),
hereby allege as follows:
THE PARTIES
1. Plaintiff Eli Lilly and Company (Lilly) is a corporation organized and existing
under the laws of the State of Indiana and has a principal place of business at Lilly Corporate
Center, Indianapolis, Indiana 46285.
2. Plaintiff Daiichi Sankyo Co., Ltd. (Daiichi Sankyo) is a corporation organized
and existing under the laws of Japan and has a principal place of business at 3-5-1, Nihonbashi-
honcho, Chuo-ku, Tokyo 103-8426, Japan.
3. Plaintiff Daiichi Sankyo, Inc. (DSI) is a corporation organized and existing
under the laws of the State of Delaware and has a principal place of business at Two Hilton
Court, Parsippany, New Jersey 07054.
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4. DSI is a wholly-owned subsidiary of Daiichi Sankyo U.S. Holdings, Inc., which is
a corporation organized and existing under the laws of the State of Delaware and has a principal
place of business at Two Hilton Court, Parsippany, New Jersey 07054.
5. Daiichi Sankyo U.S. Holdings, Inc. is a wholly-owned subsidiary of Daiichi
Sankyo.
6. Plaintiff Ube Industries, Ltd. (Ube) is a corporation organized and existing
under the laws of Japan and has a principal place of business at 1978-96, Kogushi, Ube,
Yamaguchi 755-8633, Japan.
7. Defendant HEC Pharm is a corporation organized and existing under the laws of
China and has a principal place of business at Binjiang Road 62, Yidu, Yichang, 443300, China.
8. Defendant HEC Pharm US is a corporation organized and existing under the laws
of Delaware and has a principal place of business at 116 Village Blvd., Suite 200, Princeton, NJ
08540.
9. Upon information and belief, the acts of HEC Pharm complained of herein were
done with the cooperation, participation, and assistance of HEC Pharm US.
NATURE OF THE ACTION
10. This is a civil action for patent infringement under the Patent Laws of the United
States, 35 U.S.C. 100 et seq., arising out of the filing by HEC of an Abbreviated New Drug
Application (ANDA) with the United States Food and Drug Administration (FDA) seeking
approval to manufacture and sell generic versions of Lillys pharmaceutical products, Effient
5mg and 10mg tablets prior to the expiration of Daiichi Sankyos and Ubes United States Patent
No. 8,404,703, of which Lilly is an exclusive licensee, which covers methods of using Effient
products.
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JURISDICTION AND VENUE
11. This patent infringement action arises under the United States Patent Laws, 35
U.S.C. 100 et seq., including 35 U.S.C. 271(e)(2). This Court has subject matter jurisdiction
under 28 U.S.C. 1331, 1338(a), 2201, and 2202.
12. This Court has personal jurisdiction over HEC Pharm because, among other
reasons, HEC Pharm has directed its intentionally infringing conduct toward Plaintiffs, including
Lilly, which has a principal place of business in Indiana. Upon information and belief, following
any FDA approval of HECs ANDA for generic versions of Effient, HEC Pharm knows and
intends that its generic products will be marketed, distributed, and sold throughout the United
States and within Indiana and the Southern District of Indiana, and knows that Lilly will be
injured by such actions in Indiana and the Southern District of Indiana.
13. Furthermore, upon information and belief, HEC Pharm markets, sells, and
distributes generic drugs throughout the United States, either directly or through HEC Pharm US,
including within the State of Indiana and the Southern District of Indiana, and enjoys substantial
income from the sales of those drugs in this State. Upon information and belief, HEC Pharm has
engaged in and maintained systematic and continuous business contacts within the State of
Indiana and the Southern District of Indiana and has purposefully availed itself of the benefits
and protections of the laws of Indiana.
14. This Court has personal jurisdiction over HEC Pharm US because, among other
reasons, HEC Pharm US has directed its intentionally infringing conduct toward Plaintiffs,
including Lilly, which has a principal place of business in Indiana. Upon information and belief,
following any FDA approval of HECs ANDA for generic versions of Effient, HEC Pharm US
intends to market, sell, and distribute these generic products throughout the United States and
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within Indiana and the Southern District of Indiana, and knows that Lilly will be injured by such
actions in Indiana and the Southern District of Indiana.
15. Furthermore, upon information and belief, HEC Pharm US markets, sells, and
distributes generic drugs throughout the United States, including within the State of Indiana and
the Southern District of Indiana, and enjoys substantial income from the sales of those drugs in
this State. Upon information and belief, HEC Pharm US has engaged in and maintained
systematic and continuous business contacts within the State of Indiana and the Southern District
of Indiana and has purposefully availed itself of the benefits and protections of the laws of
Indiana.
16. Venue is proper in this judicial district pursuant to 28 U.S.C. 1391 and
1400(b).
THE PATENT-IN-SUIT
17. On March 26, 2013, the USPTO duly and legally issued United States Patent No.
8,404,703 (the 703 patent), entitled Medicinal Compositions Containing Aspirin. The 703
patent is assigned to Daiichi Sankyo and Ube. A copy of the 703 patent is attached as
Exhibit A.
FACTUAL BACKGROUND
Effient Products
18. Lilly is an exclusive licensee to the 703 patent, which covers methods of using
Effient products.
19. Effient products were approved by the FDA for the reduction of thrombotic
cardiovascular events in certain patients with acute coronary syndrome (ACS) who are to be
managed with percutaneous coronary intervention (PCI, or angioplasty).
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20. Effient products contain prasugrel hydrochloride, which is known as 5-[(1RS)-
2-cyclopropyl-1-(2-fluorophenyl)-2-oxoethyl]-4,5,6,7-tetrahydrothieno[3,2-c]pyridin-2-yl
acetate hydrochloride or 2-acetoxy-5-(-cyclopropylcarbonyl-2-fluorobenzy1)-4,5,6,7-
tetrahydrothieno[3,2-c]pyridine hydrochloride.
21. Effient products are formulated in two strengths, EQ 5 mg or EQ 10 mg base of
prasugrel hydrochloride, where the EQ 10 mg base dose is the reference listed drug.
22. The instructions accompanying Effient products state that patients taking
Effient products should also take aspirin.
23. The use of Effient products in combination with aspirin for the reduction of
thrombotic cardiovascular events in patients with ACS who are to be managed with PCI is
covered by the claims of the 703 patent.
24. Lilly holds an approved New Drug Application, No. 22-307, for the manufacture
and sale of Effient products, 5 mg and 10 mg prasugrel hydrochloride tablets, in the United
States (the Effient NDA).
25. Lilly currently markets Effient products in the United States.
26. DSI currently co-promotes Effient products in the United States with Lilly.
27. Pursuant to 21 U.S.C. 355(b)(1) and attendant FDA regulations, the 703 patent
is listed in the FDA publication, Approved Drug Products with Therapeutic Equivalence
Evaluations (the Orange Book), as covering Effient products.
Infringement by HEC
28. HEC has knowledge of the 703 patent and has submitted Abbreviated New Drug
Application No. 206021 (the HEC ANDA) to the FDA pursuant to 21 U.S.C. 355(j), seeking
approval to market prasugrel hydrochloride tablets for oral administration (the HEC Products)
in the United States prior to the expiration of the 703 patent.
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29. The active ingredient and strength of the HEC Products is 5 mg and 10 mg EQ
base of prasugrel hydrochloride.
30. On or about May 24, 2014, HEC Pharm sent Lilly and Daiichi Sankyo a letter,
dated May 24, 2014, and an attached memorandum (collectively, the HEC Notification) stating
that HEC had included within its ANDA a certification pursuant to 21 U.S.C.
355(j)(2)(A)(vii)(IV) that the 703 patent is invalid, unenforceable, and/or will not be infringed
by the manufacture, use, importation, sale or offer for sale of the HEC Products in the United
States (HEC Paragraph IV Certification).
31. The prasugrel hydrochloride active ingredient in the HEC Products is the same as
the prasugrel hydrochloride active ingredient in Effient products. 21 U.S.C. 355(j)(2); 21
C.F.R. 314.94(a)(5).
32. The HEC ANDA refers to and relies upon the Effient NDA and contains data
that, according to HEC, demonstrates that the HEC Products and Effient products are
bioequivalent. 21 U.S.C. 355(j)(2); 21 C.F.R. 314.94(a)(7).
33. HEC will knowingly accompany the HEC Products with instructions for use that
substantially copy the instructions for Effient products, including instructions for administering
the HEC Products with aspirin as claimed in the 703 patent. 21 U.S.C. 355(j)(2); 21 C.F.R.
314.94(a)(4), and (8).
34. HEC knows that the instructions that will accompany the HEC Products will
induce and/or contribute to others using the HEC Products in the manner set forth in the
instructions.
35. Physicians, health care providers, and/or patients will directly infringe one or
more claims of the 703 patent by using the HEC Products in accordance with the instructions
provided by HEC, after the FDA approves the HEC ANDA.
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36. HEC specifically intends that physicians, health care providers, and/or patients
will use the HEC Products in accordance with the instructions provided by HEC to directly
infringe one or more claims of the 703 patent. HEC therefore will actively induce and/or
contribute to infringement of the 703 patent.
37. HEC knowingly has taken and intends to take active steps to induce and/or
contribute to physicians, health care providers, and/or patients using the HEC Products in a
manner that directly infringes at least one claim of the 703 patent.
38. HEC designed the HEC Products for use in a way that would infringe the 703
patent and will instruct users of the HEC Products to use the HEC Products in a way that would
infringe the 703 patent.
39. The HEC Products are not a staple article or commodity of commerce suitable for
substantial non-infringing use.
40. Unless HEC is enjoined by the Court, Plaintiffs will be substantially and
irreparably harmed by HECs infringement of the 703 patent. Plaintiffs do not have an adequate
remedy at law.
41. Plaintiffs commenced this action within 45 days of receiving the HEC
Notification.
COUNT I: INFRINGEMENT OF U.S. PATENT NO. 8,404,703
42. Plaintiffs reallege and incorporate by reference the allegations contained in
Paragraphs 1-41.
43. HECs filing of the HEC ANDA containing the HEC Paragraph IV Certification
for the purpose of obtaining FDA approval to engage in the commercial manufacture, use,
importation, offer to sell and/or sale or inducement thereof of either or both of the HEC Products
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in the United States before the expiration of the 703 patent is an act of patent infringement
under 35 U.S.C. 271(e)(2)(A).
44. If the FDA approves the HEC ANDA, HEC plans to, intends to, and will
commercially manufacture, use, sell and/or offer to sell either or both of the HEC Products in the
United States, import either or both of the HEC Products into the United States, and/or induce
such acts during the term of the 703 patent.
45. HEC has taken and intends to take active steps to induce, or contribute to, the
infringement of the 703 patent under 35 U.S.C. 271(b) and/or 271(c), if the HEC ANDA is
approved.
46. HEC lacked a good faith basis for alleging invalidity of the 703 patent when it
filed the HEC ANDA and made the HEC Paragraph IV Certification. Accordingly, the HEC
Paragraph IV Certification was wholly unjustified.
COUNT II: DECLARATORY JUDGMENT OF INFRINGEMENT
OF U.S. PATENT NO. 8,404,703
47. Plaintiffs reallege and incorporate by reference the allegations contained in
Paragraphs 1-46.
48. This count arises under the Declaratory Judgment Act, 28 U.S.C. 2201 and
2202.
49. HEC has taken and intends to take active steps to induce, or contribute to, the
infringement of the 703 patent under 35 U.S.C. 271(b) and/or 271(c), if the HEC ANDA is
approved.
50. Plaintiffs are entitled to a declaration that the commercial manufacture, use, sale
and/or offer to sell of either or both of the HEC Products in the United States, importation of
either or both of the HEC Products into the United States, and/or the inducement of such acts
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during the term of the 703 patent will induce and/contribute to the infringement of the 703
patent.
PRAYER FOR RELIEF
WHEREFORE, Plaintiffs pray for a judgment in their favor against Defendants as
follows:
A. That HEC, either individually or collectively, has infringed the 703 patent and/or
will infringe, actively induce infringement of, and/or contribute to infringement by others of one
or more claims of the 703 patent;
B. That, pursuant to 35 U.S.C. 271(e)(4)(B), HEC, its officers, agents, servants,
and employees, and those persons in active concert or privity with any of them are permanently
enjoined from making, using, selling or offering to sell either or both of the HEC Products within
the United States, or importing either or both of the HEC Products into the United States prior to
the expiration of the 703 patent;
C. That, pursuant to 35 U.S.C. 271(e)(4)(A), the effective date of any approval of
the HEC ANDA under 505(j) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 355(j))
shall not be earlier than the expiration date of the 703 patent, including any extensions.
D. If HEC commercially makes, uses, sells or offers to sell either or both of
the HEC Products within the United States, or imports either or both of the HEC Products
into the United States, prior to the expiration of the 703 patent, including any extensions,
that Plaintiffs will be awarded monetary damages for those infringing acts to the fullest
extent allowed by law and be awarded prejudgment interest based on those monetary
damages;
E. That this case be deemed exceptional under 35 U.S.C. 285;
F. A judgment declaring that the 703 patent is valid and enforceable;
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G. That Plaintiffs be awarded reasonable attorneys fees, costs, and expenses; and
H. That Plaintiffs be awarded such other relief as the Court deems just and proper.
Dated: July 7, 2014 /s/ Jan M. Carroll
Jan M. Carroll
Barnes & Thornburg LLP
11 South Meridian Street
Indianapolis, IN 46204
317-236-1313
jan.carroll@btlaw.com
Attorney for Plaintiffs
Eli Lilly and Company, Daiichi Sankyo Co.,
Ltd., Daiichi Sankyo, Inc., and Ube
Industries, Ltd.
INDS02 1328564v1
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